Phase 1b Study of a Cancer Vaccine to Treat Patients With Advanced Stage Ovarian, Fallopian or Peritoneal Cancer
Status: | Active, not recruiting |
---|---|
Conditions: | Ovarian Cancer, Cancer, Cancer, Cancer, Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/8/2017 |
Start Date: | August 23, 2013 |
End Date: | November 30, 2017 |
Phase 1b Study of Extended Dosing of an Immunotherapeutic Vaccine, DPX-Survivac With Low Dose Cyclophosphamide in Patients With Surgically Operable or Advanced Stage Ovarian, Fallopian Tube or Peritoneal Cancer.
As a follow-on study to NCT01416038, this study is designed to identify the optimal dosage of
immunotherapeutic survivin vaccine DPX-Survivac and low dose oral cyclophosphamide. The
combination treatment is being evaluated in a non-randomized, multi-cohort study as
post-chemotherapy treatment for patients with late-stage ovarian, fallopian tube, or
peritoneal cancer.
immunotherapeutic survivin vaccine DPX-Survivac and low dose oral cyclophosphamide. The
combination treatment is being evaluated in a non-randomized, multi-cohort study as
post-chemotherapy treatment for patients with late-stage ovarian, fallopian tube, or
peritoneal cancer.
Key Inclusion Criteria:
- Histologically confirmed stage IIc-IV epithelial ovarian, fallopian tube or peritoneal
cancer
- Complete or partial response following standard of care surgery and first line
chemotherapy
- May have one disease recurrence with complete or partial response or stable disease
following standard of care second line care treatment
- Previous investigational biologic therapy allowed, must be more than 56 days prior to
first injection
- Previous treatment with bisphosphonate allowed, must be completed 14 days prior to
first injection
- Ambulatory with an ECOG 0-1
- Life expectancy > 6 months
- Meet protocol-specified lab requirements
- Provide informed consent and have ability to comply with protocol requirements
Key Exclusion Criteria:
- Concurrent chemotherapy, radiation therapy, immunotherapy are excluded (washout
periods as specified in protocol)
- Prior receipt of survivin based vaccines
- Participation in prior therapeutic adjuvant ovarian cancer studies, except for
platinum-based adjuvant studies
- Progressive disease (rising CA-125 acceptable)
- More than one course of chemotherapy for recurrent disease
- Concurrent bevacizumab as maintenance therapy
- Concurrent second malignancy other than non-melanoma skin cancer, cervical carcinoma
in situ, or controlled bladder cancer
- History of autoimmune disease
- Recent history of thyroiditis
- Presence of a serious acute infection or chronic infection
- Brain metastases
- Other serious intercurrent chronic or acute illness
- Ongoing treatment with steroid therapy or other immunosuppressive
- Acute or chronic skin disorders
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Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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